Single Use Injector

ABSTRACT

A single use injector is a disposable injection device that is specifically optimized for production using the blow fill seal (BFS) manufacturing process and includes various mechanisms that render the device inoperable and facilitate its safe disposal after use. The single use injector incorporates an ampoule aseptically filled with a medication that is coupled to a hermetically sealed component system. The hermetically sealed component system incorporates various mechanisms that are actuated during the use of the injection device. The injection device is encased in a removable overtube that prevents contamination. upon removal of the overtube, the injection device is activated, by compression of a needle cap that irreversible punctures the ampoule in order to inject the medication through a needle. The injection device additionally incorporates a shield that deploys over the needle following injection of the medication into a patient.

The current application is a continuation-in-part (CIP) application of aU.S. non-provisional application Ser. No. 14/634,537 filed on Feb. 27,2015. The U.S. non-provisional application Ser. No. 14/634,537 is a CIPapplication of a U.S. non-provisional application Ser. No. 14/052,167filed on Oct. 11, 2013. The U.S. non-provisional application Ser. No.14/052,167 is a CIP application of a U.S. non-provisional applicationSer. No. 13/870,815 filed on Apr. 25, 2013. The U.S. non-provisionalapplication Ser. No. 13/870,815 claims a priority to the PatentCooperation Treaty (PCT) application serial number PCT/US12/47531 filedon Jul. 20, 2012. The PCT application serial number PCT/US12/47531claims a priority to a U.S. provisional application Ser. No. 61/638,059filed on Apr. 25, 2012.

FIELD OF THE INVENTION

The present invention relates generally to a single use syringe, morespecifically to a prefilled single use medical injection device that isparticularly designed for the Blow Fill Seal manufacturing process. Allor parts of this device are now designed for the injection moldingprocess. This application is for either blow fill seal processes and/orthe injection molding process.

BACKGROUND OF THE INVENTION

There exists a plurality of the hypodermic syringe type injection deviceavailable for use. The vast majority of the devices are derivative ofFrench physician Charles Pravaz' well-known design. The design consistsof a cylinder body, a piston, and a hypodermic needle. This design worksvery well for introducing and extracting fluids from patients and hasbeen adapted recently as a prefilled delivery method made suitable byfollowing specific pre-determined safety protocols that add significantcost to the infusion equation.

Prefilled medical injection devices provide health care workers with amore efficient way to administer medications. The ubiquitous hypodermicsyringe has seen a multitude of incremental advancements andimprovements over the years in order to deal with the myriad of problemshypodermic syringes present in its manufacture, distribution, storageand use. Many of these advancements are unique to the problems relatingto the prefilled syringe, which creates many new challenges because ofthe prefilled format. For example, prefilled hypodermic syringes faceproblems relating to chemical interactions with silicone, a commonlubricant that allows the plunger to move down the cylinder, as well asadhesives, rubber, and tungsten. Further, transportation presentsadditional problems relating to atmospheric changes, creating apotential for pressure increases inside the cylinder body causing thedevice to extrude medication, wasting medication, while decreases causethe device to suction up outside air, which increases the risk ofcontamination. Many other problems exist in their use, such as theaccidental removal or dislodgement of the plunger, as well as thepotential for needle stick injury depending upon the type of needleused. This has been a problem to many health care professionals and hasforced them to switch back to the vial syringe method for deliveringvaccinations.

Although, there are multitudes of prior arts that incorporate solutionsto the above problem the majority of them still carry a majordisadvantage. The majority of injection devices require that the devicebe uncapped and recapped to avoid sticking others with a contaminatedneedle. The requirement to recap a syringe has created a major riskfactor for healthcare workers, accidentally pricking themselves with asoiled needle. It is therefore an object of the present invention tointroduce a device that is prefilled with medication, adjusts to changesin ambient temperature and pressure, while providing a risk reducingmechanism to inject patients. Additionally, the invention is designedfor a mass production method (Blow-Fill-Seal method) that minimizes therisk of contamination. Blow-Fill-Seal has numerous requirements andlimitations and the ampoule and collar (insertion technology) have bothbeen designed to be compatible with Blow-Fill-Seal manufacturing. Thisdesign combines the separate plastic syringe manufacturing process andthe subsequent filling of the syringe with a liquid in a separatefilling process. Currently the prefilled syringe concept uses two ormore separate and distinct machines to create a prefilled syringe with arubber stopper inside the syringe. None of these devices have a rubberstopper which is used to push the liquid out the end.

BRIEF DESCRIPTIONS OF THE DRAWINGS

FIG. 1 is a perspective view displaying the single use injector in theinitial configuration.

FIG. 2 is an expanded perspective view displaying the components of thesingle use injector in the initial configuration.

FIG. 3 is a perspective view displaying a transition stage of the singleuse injector where the overtube is being rotated to facilitateseparation at the frangible features.

FIG. 4 is a perspective view displaying a transition stage of the singleuse injector where the overtube is being pulled off.

FIG. 5 is a sectional view displaying the needle assembly coupled to thefirst pair of slots as per the initial configuration.

FIG. 6 is a sectional view displaying the needle assembly coupled to thesecond pair of slots as per the activated configuration.

FIG. 7 is an expanded sectional view displaying the interior regions andthe alignment of the components of the single use injector as per theactivated configuration.

FIG. 8 is a lateral view displaying the second engagement featurefollowing the first path of the needle shield activation channel.

FIG. 9 is lateral view displaying the activation tab traversing thesecond path during the deployment of the shield assembly over theneedle.

FIG. 10 is a lateral view displaying the shield assembly shrouding theneedle and the activation tabs engaged to the locking mount, as per thedeactivated configuration.

FIG. 11 is a perspective view displaying the single use injector is thedeactivated configuration.

FIG. 12 is a front view displaying an alternate embodiment of theampoule.

FIG. 13 is an exploded front view displaying an alternate embodiment ofthe ampoule.

FIG. 14 is a front view displaying another embodiment of the needle cap.

FIG. 15 is an exploded front view displaying another embodiment of theneedle cap.

DETAIL DESCRIPTIONS OF THE INVENTION

All illustrations of the drawings are for the purpose of describingselected versions of the present invention and are not intended to limitthe scope of the present invention.

Referencing FIG. 1, FIG. 2, and FIG. 7, the single use injector is adisposable injection device that is specifically optimized forproduction using the blow fill seal (BFS) manufacturing process andincludes various mechanisms that render the device inoperable andfacilitate its safe disposal after use. The single use injectorcomprises an insert body 2, a needle assembly 3, a shield assembly 4,and an ampoule 1. The ampoule 1 is the liquid filled volume createdusing the BFS process. The ampoule 1 is attached to the insert body 2through a parison layer. The insert body 2 is rigid in construction andenables interactions between the needle assembly 3 and the ampoule 1.The needle assembly 3 penetrates the ampoule 1 through the insert body 2and provides a conduit for injecting the contents of the ampoule 1 intoa patient. The shield assembly 4 is a safety component thatautomatically extends over the needle 35 of the needle assembly 3 afteruse.

Referencing FIGS. 3-6 and FIGS. 8-10, the single use injectorincorporates several mechanisms that render the injector inoperable aswell as facilitate its safe disposal after use. The mechanisms involveinteractions between two or more components that result in thealteration of the placement or configuration of at least one component.In the current embodiment of the present invention, the single useinjector comprises three main configurations, an initial configuration,an activated configuration, and a deactivated configuration. Theactivated configuration is characterized by the needle assembly 3puncturing the prefilled chamber 10 of the ampoule 1. The deactivatedconfiguration is characterized by the volume of the prefilled chamber 10being emptied and the ampoule 1 being in a fully compressed state whilethe shield assembly 4 being deployed and fully shrouding the needle 35.It should be noted that each configuration precedes or follows aninteraction by a user that occurs as a result of operating the singleuse injector.

Referencing FIG. 2 and FIG. 5-7, in the current embodiment of thepresent invention, the insert body 2 provides an engagement point forthe ampoule 1 and the needle assembly 3. The insert body 2 iscylindrically shaped and comprises an upper section 20, a cylindricalwall 23, and an inner chamber 24. The inner chamber 24 is the hollowinterior of the insert body 2 that is accessible through a chamberopening 241. The cylindrical wall 23 surrounds the inner chamber 24 andcomprises various features for engaging the needle assembly 3. The uppersection 20 is positioned opposite the chamber opening 241 across thecylindrical wall 23 and serves as a mounting point for the ampoule 1.The upper section 20 is pierced by the needle assembly 3 in order toreach the ampoule 1.

Referencing FIG. 2 and FIG. 5-7, upper section 20 is particularly formedto interact with the ampoule 1 and the needle assembly 3. The uppersection 20 is positioned generally perpendicular to the cylindrical wall23. The upper section 20 of the insert body 2 comprises knurl features21 and a collar 22. The knurl features 21 of the upper section 20 are anarray of ridges positioned on the perimeter edge of the upper section 20where it becomes coincident with the cylindrical wall 23. The knurlfeatures 21 provide additional surface area to upper section 20 thatimproves the attachment and retention of the ampoule 1 to the uppersection 20. The collar 22 is a protruding feature that extends centrallyfrom the upper section 20 towards the ampoule 1. In the currentembodiment of the present invention, the upper section 20 tapperstowards the collar 22. The collar 22 comprises knurl features that areperimetrically positioned around the exposed portion of collar 22 on theupper section 20. The knurl features 220 of the collar 22 facilitateattachment and improve retention of the ampoule 1. The collar 22additionally comprises a guide shaft 221 and a septum 222. The guideshaft 221 is a hollow shaft that traverses centrally through the uppersection 20. The septum 222 functions as a barrier between the guideshaft 221 and the inner chamber 24. The septum 222 is pierced by theneedle 35 of the needle assembly 3 in order to puncture the ampoule 1.The positioning of the guide shaft 221 to the needle assembly 3 isprovided as a means of guiding the needle 35 after it pierces throughthe septum 222. It should be noted that the diameter of the guide shaft221 is only slightly larger than that of the needle 35, in order toensure that the walls of the guide shaft 221 are able to orient theneedle 35 effectively.

Referencing FIG. 2 and FIG. 5-7, the cylindrical wall 23 surrounds theinner chamber 24 and is bounded by the chamber opening 241 and the uppersection 20. The cylindrical wall 23 interacts with the needle assembly 3during the transition between the initial configuration and theactivated configuration. The cylindrical wall 23 comprises a first pairof slots 231, a second pair of slots 232, and a pair of alignmentchannels 230.

Referencing FIG. 2 and FIG. 5-7, the first pair of slots 231 and thesecond pair of slots 232 function as part of a locking mechanism thatprevents the needle assembly 3 from returning to the initialconfiguration. The first pair of slots 231 and the second pair of slots232 are aligned on the cylindrical wall 23 to engage a pair of snappinghooks 34 of the needle assembly 3 as the needle assembly 3 moves towardsthe upper section 20. Each snapping hook 34 of the pair of snappinghooks 34 is positioned oppositely on the needle assembly 3. As such eachslot of the first pair of slots 231 is positioned on the cylindricalwall 23 across the inner chamber 24, while each slot of the second pairof slots 232 is positioned on the cylindrical wall 23 across the innerchamber 24. The first pair of slots 231 and the second pair of slots 232are associated with a particular configuration of the single useinjector. The first pair of slots 231 is associated with the initialconfiguration while the second pair of slots 232 is associated with theactivated configuration. As a result of the second pair of slots 232association with the activated configuration, the second pair of slots232 are positioned adjacent the upper section 20, relative to the firstpair of slots 231. Furthermore, the interior surface of the cylindricalwall 23 is angled towards the upper section 20 resulting in a narrowingof the inner chamber 24 which improves engagement with the second pairof slots 232.

Referencing FIG. 1, FIG. 2 and FIG. 5-7, the pair of alignment channels230 are recessed features positioned on the portion of the cylindricalwall 23 coincident with the inner chamber 24, adjacent to the chamberopening 241. The pair of alignment channels 230 are complementaryfeatures to a pair of guides 38 positioned on the lateral wall 31 of theneedle assembly 3. The pair of guides 38 are semicircular protrusionsoppositely positioned on the exterior surface of the needle assembly 3adjacent to the cavity opening 39 of the needle assembly 3. Each guideof the pair of guides 38 is found coincident within an alignment channel230 of the pair of alignment channels 230. The positioning of each guidewith an alignment channel 230 restricts the movement of the needleassembly 3 within the inner chamber 24 to follow along the path of thealignment channel 230. The engagement between the pair of alignmentchannels 230 and the pair of guides 38 prevents unwanted lateralrotation of the needle assembly 3 as it transitions from the initialconfiguration to the activated configuration.

Referencing FIG. 2 and FIG. 5-7, the inner chamber 24 of the insert body2 receives the needle assembly 3. The needle assembly 3 is containedwithin the inner chamber 24 and the engagement between the cylindricalwall 23 and the needle assembly 3 restrict its movement whiletransitioning between the initial and activated configuration.Interactions between the inner chamber 24 and the needle assembly 3occur through a conical shaped needle mount 30 of the needle assembly 3and a conical shaped cavity 240 within the inner chamber 24. The conicalshaped cavity 240 is a concave feature that is positioned within theinner chamber 24 and coincident with the upper section 20. The conicalshaped cavity 240 is positioned centrally to the upper section 20 withinthe inner chamber 24. As a result of the positioning, the conical shapedcavity 240 is centrally aligned with the septum 222 of the collar 22.The walls of the conical shaped cavity 240 narrow towards the uppersection 20. The narrowing walls serve to guide the conical shaped needlemount 30 towards the center in order to penetrate the septum 222. Theconical shaped cavity 240 is particularly formed to receive the conicalshaped needle mount 30 of the needle assembly 3 during the transitionfrom the initial configuration to the activated configuration. Theconical shaped cavity 240 is slightly smaller in diameter than theconical shaped needle mount 30. The disparity in size causes the conicalshaped needle mount 30 to wedge itself into the conical shaped cavity240 forming a gasket-like seal when the needle 35 transitions in theactivated configuration.

Referencing FIG. 1, FIG. 2, and FIG. 5-7, the needle assembly 3 isparticularly shaped to interact with the insert body 2, the shieldassembly 4, and the ampoule 1. The needle assembly 3 is cylindricallyshaped, similar to the insert body 2 and the shield assembly 4 butcomprises various laterally positioned features to engage both the insetbody and the shield assembly 4. The needle assembly 3 comprises alateral wall 31, a cavity 33, a conical shaped needle mount 30, a spring36, and a needle 35. The lateral wall 31 surrounds the cavity 33 of theneedle assembly 3 and serves as the engagement point for variousinteracting features. The lateral wall 31 is bounded by the conicalshaped needle mount 30 and the cavity 33 opening. The cavity 33 is theinterior region of the needle assembly 3 that is surrounded by thelateral wall 31. The spring 36 is contained within the cavity 33 andcompressed by the shield assembly 4. The shield assembly 4 is positionedwithin the cavity 33 of the needle assembly 3, retained by a pair ofengagement features interacting with the lateral wall 31. The conicalshaped needle mount 30 is positioned on the exterior of the needleassembly 3 adjacent the conical shaped cavity 240 of the insert body 2.The needle 35 is the conduit that is centrally poisoned on the needleassembly 3 traversing the conical shaped needle mount 30 and through thecavity 33. The needle 35 punctures the ampoule 1 enabling the contentsof the prefilled chamber 10 to be injected into a patient.

Referencing FIG. 2 and FIG. 5-7, the conical shaped needle mount 30 ispositioned on the exterior portion of the needle assembly 3. When viewedlaterally, the conical shaped needle mount 30 has a trapezoidal profile.The conical shaped needle mount 30 is centrally traversed by the needle35. The puncturing end 350 of the needle 35 centrally protrudes from theconical shaped needle mount 30 towards the conical shaped cavity 240.The length of the puncturing end 350 of the needle 35 is sufficient topenetrate the septum 222, traverse the guide shaft 221, and pierce amembrane 11 of the prefilled chamber 10. The conical shaped needle mount30 becomes coincident with the conical shaped cavity 240. The conicalshaped needle mount 30 has a slightly larger diameter than conicalshaped cavity 240. The larger diameter allows the conical shaped needlemount 30 wedge into the conical shaped cavity 240 when the needleassembly 3 is being positioned into the activated configuration.

Referencing FIG. 1, FIG. 2 and FIG. 5-7, the lateral wall 31 of theneedle assembly 3 is positioned surrounding the cavity 33 and the needle35. The lateral wall 31 bounded by the conical shaped needle mount 30and the cavity 33 opening. The lateral wall 31 comprises severalfeatures that directly engage the insert body 2 and the shield assembly4. These features comprise a pair of snapping hooks 34, needle shieldactivation channels 32, and a pair of guides 38. The pair of snappinghooks 34 are the interacting features that engage the first pair ofslots 231 and the second pair of slots 232. Each snapping hook 34 of thepair of snapping hooks 34 are oppositely positioned on the exteriorportion of the lateral wall 31. The positioning of each snapping hook 34permits a coincident alignment with the first pair of slots 231 and thesecond pair of slots 232.

Furthermore, a corresponding snapping hook among the pair of snappinghooks 34 is accommodated within a corresponding lateral through holeamong a pair of lateral through holes of the lateral wall 31.

Referencing FIG. 5-7, each snapping hook 34 of the pair of snappinghooks 34 comprises a flexible arm 340 and a stud 341. The flexible arm340 and the stud 341 function as a pawl for disengaging and engaging thefirst pair of slots 231 and the second pair of slots 232 in onedirection. The flexible arm 340 is connected to the lateral wall 31,while the stud 341 is terminally positioned on the opposite end of theflexible arm 340 relative to the connection with the lateral wall 31.The positioning of the stud 341 relative to the connection enables thestud 341 to compress and pivot through as a result of the elasticconstruction of the flexible arm 340. Furthermore, the stud 341 and theflexible arm 340 are compressed inwardly towards the cavity 33 inresponse to the stud 341 moving in between a corresponding slot amongthe first pair of slots 231 and a corresponding slot among the secondpair of slots 232.

Referencing FIG. 5, FIG. 6, and FIG. 7, during the initialconfiguration, the stud 341 is positioned within a slot of the firstslot. When the needle assembly 3 begins to move towards the uppersection 20 during the transition stage, the stud 341 disengages from theslot of the first pair of slots 231 and becomes coincident with theinterior surface of the cylindrical wall 23 as a result of thecompression of the flexible arm 340. The compression of the flexible arm340 allows the stud 341 to traverse the space between the first pair ofslots 231 and the second pair of slots 232. When the stud 341 alignswith a slot of the second pair of slots 232, the flexible arm 340relaxes and moves the stud 341 into a secure engagement with the secondpair of slots 232.

It should be noted that the stud 341 incorporates sloped feature thatallow for facilitated disengagement from the slot of the first pair ofslots 231 while moving towards the upper section 20 while incorporatingfeature that prevent disengagement in the reverse direction.Additionally, it should be noted that the stud 341 and the flexible arm340 compress inwardly towards the cavity 33 of the needle assembly 3while moving towards the upper section 20. Additionally, the pair ofsnapping hooks 34 is configured to be detachably coupled to the firstpair of slots 231 by the stud 341. In further detail, the stud 341 isdetachably engaged with a corresponding slot among the first pair ofslots 231 in order to allow the user to attach or remove the pair ofsnapping hooks 34 to or from the first pair of slots 231. Similarly, thepair of snapping hooks 34 is configured to be detachably coupled to thesecond pair of slots 232 by the stud 341. In further detail, the stud341 is detachably engaged with a corresponding slot among the secondpair of slots 232 in order to allow the user to attach or remove thepair of snapping hooks 34 to or from the second pair of slots 232.

Referencing FIG. 1 and FIG. 2, the pair of guides 38 are oppositelypositioned on the exterior portion of the lateral wall 31 adjacent tothe cavity 33 opening. Each guide of the pair of guides 38 becomescoincident with an alignment channel 230 of the pair of alignmentchannels 230 on the interior surface of the cylindrical wall 23. Thecoincident engagement between each guide and an alignment channel 230 ofthe pair of alignment channels 230 prevents the needle assembly 3 fromrotating while moving into the activated configuration.

Referencing FIG. 2 and FIG. 7-10, the needle shield activation channels32 interact with activation tabs 41 of the shield assembly 4 in order todeploy the shield assembly 4 over the needle 35. The needle shieldactivation channels 32 guide the shield assembly 4 from its initialposition, retained within the cavity 33 of the needle assembly 3, andtransitions it to a deployed position in the deactivated configuration,shrouding the needle 35. The needle shield activation channels 32comprise a first path 320, a second path 321, and an obstructing feature323. The first path 320 and the second path 321 are excised from thelateral wall 31. The second path 321 is oriented from conical shapedneedle mount 30 towards the cavity 33 opening. The first path 320intersects the second path 321 proximal to the conical shaped needlemount 30. The intersect of the first path 320 and the second path 321form an acute angle with the opening facing the towards the cavity 33opening. The positioning of the first path 320 relative to the secondpath 321 is provided to direct the activation tab 41 towards the secondpath 321 during compression of the shield assembly 4. The obstructingfeature 323 is positioned in the angle opening formed by the first path320 and the second path 321. The obstructing feature 323 preventsrotation of the shield assembly 4 from repositioning the activation tab41 into the second path 321. The obstructing feature 323 retains anactivation tab 41 within the first path 320 until the shield assembly 4is compressed against a patient.

Referencing FIG. 2 and FIG. 8, the compression of the shield assembly 4causes an activation tab 41 to travel along the first path 320 until.The activation tab 41 continues traveling along the first path 320 untilthe reaching the intersect point of the first path 320 and the secondpath 321. When that activation tab 41 is coincident with the second path321, the spring 36 is able to extend the shield assembly 4 the length ofthe second path 321, until the activation tab 41 becomes coincident witha locking mount 322 of the second path 321. The locking mount 322 ispositioned proximal to the cavity opening 39 of the second path 321 andsecurely engages the activation tab 41. The engagement between theactivation tab 41 and the locking mount 322 prevents the shield assembly4 from returning back to its position in the activated configuration.

Referencing FIG. 7, the cavity 33 is surrounded by the lateral wall 31and contains the shield assembly 4 and the spring 36 during theactivated configuration. The cavity 33 is accessible through a cavityopening 39 positioned perpendicular to the lateral wall 31 opposite thepositioning of the conical shaped needle mount 30. The shield assembly 4traverse into the cavity 33 through cavity opening 39 and is retainedwithin the cavity 33 by the engagements with the lateral wall 31 throughthe needle shield activation channels 32. The cavity 33 houses thespring 36 that is compressed by the shield assembly 4. Within the cavity33, a tapered spring mount 37 is positioned centrally through the cavity33 with the mounting point found within the cavity 33 opposite theconical shaped needle mount 30. The tapered spring mount 37 is centrallytraversed by the needle 35 and is sleeved by the spring 36. The taperedspring mount 37 is a long cone shaped rigid body that prevents thespring 36 from buckling. The spring 36 is compressed by the shieldassembly 4 within the cavity 33. The spring 36 comprises a first springend 360 and a second spring end 361 end. The first spring end 360sleeves the tapered spring mount 37 within the cavity 33 while thesecond spring end 361 end is retained against a spring mount 42 of theshield assembly 4.

Referencing FIG. 1, FIG. 2, and FIG. 7, the needle 35 is centrallypositioned through the needle assembly 3 and traverses the conicalshaped needle mount 30 and the tapered spring mount 37. The needle 35 isused to pierce the ampoule 1 and transport the fluid contents of theampoule 1 into a patient. The needle 35 comprises a puncturing end 350,an injection end 353, and a fluid conduit 354. The puncturing end 350 ofthe needle 35 is the visible portion of the needle 35 that extends fromthe conical shaped needle mount 30. The puncturing end 350 of the needle35 pierces the septum 222 and traverses the guide shaft 221 beforepuncturing the membrane 11 of the ampoule 1. In an embodiment of theinvention, the puncturing end 350 of the needle 35 comprises a roundedtip 351 and conduit opening 352. The rounded tip 351 is terminallypositioned on the puncturing end 350 and facilitates the piercing of theseptum 222. The rounded tip 351 additionally reduces the risk ofdislodged shards created from piercing the septum 222 from obstructingthe fluid conduit 354. The conduit opening 352 is positioned on thepuncturing end 350 of the needle 35 adjacent to the rounded tip 351. Theconduit opening 352 provides a passage for the fluid conduit 354. Theconduit opening 352 is particularly formed for use with the rounded tip351. After the puncturing end 350 traverses into the prefilled chamber10 of the ampoule 1, the fluid conduit 354 is used to transport thefluids through the needle 35 and through the injection end 353.

Referencing FIG. 1, FIG. 2, and FIG. 7-10, the shield assembly 4 is adeployable safety feature that shrouds the needle 35 of the needleassembly 3 after use. The shield assembly 4 is engaged to the needleshield activation channels 32 on the lateral wall 31. The shieldassembly 4 is retained within the cavity 33 during the initialconfiguration and the activated configuration. The shield assembly 4 isdeployed by the engagement with the spring 36 after the shield assembly4 is compressed during use. The shield assembly 4 comprises a barrel 40,activation tabs 41, and a spring mount 42. The barrel 40 of the shieldassembly 4 is the generally cylindrical shaped body of the shieldassembly 4. The barrel 40 sleeves the needle 35 and the spring 36. Thesecond end of the spring 36 engages the spring mount 42 within thebarrel 40. The spring mount 42 is an extension of the barrel 40 thatcomprises a needle passage 43. The needle passage 43 is the centrallypositioned opening through which the needle 35 traverses the shieldassembly 4. The needle passage 43 allows the shield assembly 4 to moveover the needle 35 while being deployed into the deactivatedconfiguration. The activation tabs 41 are positioned on the exterior ofthe barrel 40. The activations tabs are protrusions from the barrel 40that laterally engage the needle shield activation channels 32 of theneedle assembly 3. The activation tabs 41 comprise an elongated arm 410,a first engagement feature 411 and a second engagement feature 412. Theelongated arm 410 runs coincident with the walls of the barrel 40. Theelongated arm 410 is coupled to the barrel 40 adjacent to the springmount 42. The first engagement feature 411 and the second engagementfeature 412 are positioned on the distal portion of the elongated arm410 opposite the spring mount 42. The elongated arm 410 and thepositioning of the first engagement feature 411 and the secondengagement feature 412 provide the activation tabs 41 with flexiblecharacteristic allowing the positioning of the first engagement feature411 and the second engagement feature 412 to compress. The secondengagement feature 412 is the positioned further away from the springmount 42 than the first engagement feature 411. The second engagementfeature 412 is mostly perpendicular to the elongated arm 410. In theinitial configuration and the activated configuration, the secondengagement feature 412 is found coincident with the first path 320 ofthe needle shield activation channels 32 while the first engagementfeature 411 is compressed against the interior surface of the lateralwall 31. The second engagement feature 412 is retained within the firstpath 320 by the obstructing feature 323. The obstructing features 323prevent rotation of the shield assembly 4 from dislodging the secondengagement feature 412 and aligning it with the second path 321. duringthe transition between the activated state and the deactivated state,compression of the shield assembly 4 near the spring mount 42 cause thesecond engagement features 412 to become coincident with the angled edgeof the first path 320. The angled edge leads the second engagementfeature 412 towards the second path 321. Compression of the shieldassembly 4 compresses the spring 36. When the second engagement feature412 becomes coincident with the second path 321 and compression to theshield assembly 4 is stopped, the spring 36 expands moving the secondengagement feature 412 and the first engagement feature 411 along thesecond path 321 towards the cavity opening 39 of the needle assembly 3.The obstructing feature 323 is particularly formed to prevent the secondengagement feature 412 from returning to its original location by have aslopped edge that would guide the second engagement feature 412 into thesecond path 321. The first engagement feature 411 is shaped similar to awedge with the slopped edge oriented towards the spring mount 42. Thefirst engagement feature 411 engages the locking mount 322 of the secondpath 321 by slightly compressing the elongated arm 410 and then snappingback into the locking mount 322. The transition of the activation tabs41 along the needle shield activation channels 32 results in the shieldassembly 4 extending over the injection end 353 of the needle 35.

The present invention may further comprise a needle cap 5 and anovertube 6. The initial configuration is characterized by the overtube 6covering the insert body 2 and the needle cap 5 with the parison layer12 of the ampoule 1 being coupled to the parison layer 61 of theovertube 6 at the frangible features 62. The needle cap 5 protects theneedle 35 of the needle assembly 3 from contamination. The needle cap 5additionally serves as the means of activating the single use injectoras compression of the needle cap 5 towards the ampoule 1 moves theneedle assembly 3 into the activated position puncturing the ampoule 1.The overtube 6 is a removable packaging that is formed over the insertbody 2 and the needle cap 5 during the BFS process. The overtube 6separates from the single use injector at a frangible feature 62positioned adjacent to the ampoule 1 on the insert body 2.

Referencing FIG. 1-6, the needle cap 5 is a temporary enclosure for theneedle 35. The needle cap 5 is coupled to the insert body 2 andpositioned against the needle assembly 3 in the initial configuration.The needle cap 5 comprises a sleeve mount 51, a rim 52, and a protectivecover 53. In the initial configuration, the needle cap 5 is covered bythe parison layer 61 of the overtube 6. After the overtube 6 is removedthe needle cap 5 protects the user handling the single use injectoraccidental sticking. The needle cap 5 additionally provides the userwith an engageable surface to activate the single use injector. Thesleeve mount 51 is positioned around the insert body 2 near the chamberopening 241. The sleeve mount 51 isn't tightly wrapped around thecylindrical wall 23, permitting movement. The rim 52 is positionedperpendicular to the sleeve mount 51 and is found coincident with thelateral wall 31 of the needle assembly 3 adjacent to the cavity 33opening. The rim 52 is also perpendicular to the protective cover 53that surrounds the needle 35 of the needle assembly 3. During thetransition stage between the initial configuration and the activatedconfiguration, the needle cap 5 pushed in towards the ampoule 1. Theresulting action causes the rim 52 to compress against the lateral wall31 of the needle assembly 3 pushing the puncturing end 350 of the needle35 through the septum 222 and into the ampoule 1. Concurrently, the pairof snapping hooks 34 disengage from the pair of first slots and reengagewith the pair of second slots, locking the needle assembly 3 in place.With the needle assembly 3 in the activated position, the needle cap 5would be removed exposing the injection end 353 of the needle 35 forinjection into a patient.

Referencing FIG. 1, FIG. 2, and FIG. 5-10, the ampoule 1 is the fluidfilled container that is punctured by the needle 35. The ampoule 1 ispositioned adjacent to the upper section 20 of the insert body 2. Theampoule 1 comprises a prefilled chamber 10, a parison layer, and aflexible body 13. The prefilled chamber 10 is the hermetically sealedvolume that is surrounded by the flexible body 13. The prefilled chamber10 is positioned against the collar 22 of the upper section 20 of theinsert body 2. The parison layer 12 of the ampoule 1 is the samematerial that is used for the flexible body 13. The parison layer 12 ofthe ampoule 1 surrounds and engages the knurl features 21 of the uppersection 20 and the collar 22 forming a secure engagement that retainsthe prefilled chamber 10 against the upper section 20.

Referencing FIG. 1, FIG. 2, and FIG. 5-10, the prefilled chamber 10 isaseptically formed during the BFS process. The flexible body 13surrounds the prefilled chamber 10 and serves as the containing body.The material construction of the flexible body 13 provides it with anelasticity that serves as the means of compressing the volume of theprefilled chamber 10 in order to eject the contents out through thefluid conduit 354 of the needle 35. The prefilled chamber 10 comprises amedication and an inert gas. The medication is a solution that isinjected into a patient through the needle 35. The walls of the flexiblebody 13 that interact with the contents of the prefilled chamber 10 areunlikely to interact or bleed chemicals into the medication overtime,due to the material construction of the prefilled chamber 10. The inertgas is used to fill any remaining headspace. The inert gas providesresistance to volume changes due to changes in pressure and temperature.It should be noted that the inert gas can be introduced into theprefilled chamber 10 after the medication is filled the chamber. Theinert gas would then be used to replace any remaining voided space.

Referencing FIG. 1, FIG. 2, and FIG. 5-10, the prefilled chamber 10 isenclosed by the flexible body 13. A membrane 11 is positioned betweenthe prefilled chamber 10 and the upper section 20 of the insert body 2.The membrane 11 seals the prefilled chamber 10 within the flexible body13 and serves as the puncturing point for the prefilled chamber 10.During the transition stage between the initial configuration and theactivated configuration, the membrane 11 is pierced by the puncturingend 350 of the needle 35. The puncturing end 350 of the needle 35 placesthe fluid conduit 354 in communication with the injection end 353. Theprefilled chamber 10 and the membrane 11 are retained against the collar22 through the engagement between the knurl features 220 of the collar22 and the parison layer 12 of the ampoule 1. In an embodiment of thepresent invention, the membrane 11 is an adhesive membrane has anadhesive layer facing the surface of the collar 22. The adhesivemembrane provides an additional means of securing the prefilled chamber10 to the collar 22. The adhesive membrane is pierced by the puncturingend 350 of the needle 35.

Referencing FIG. 1, FIG. 2, and FIG. 5-10, the flexible body 13 thatsurrounds the prefilled chamber 10 is designed to fully eject the volumeof the prefilled chamber 10 through the needle 35. The flexible body 13accomplishes this through its particular shape. The flexible body 13comprises a first section 14 and a second section 15. The first section14 is shaped to taper towards the collar 22 and thus towards thepuncturing end 350 of the needle 35 positioned within the prefilledchamber 10. The second section 15 is symmetrical to the first section 14but opposite the wider section of the first section 14. The profile viewof the flexible body 13 appears hexagonal in the initial configurationand the activated configuration. The particular shape of the flexiblebody 13 is provided as a means of ensuring compression of the flexiblebody 13 can eject the entire volume of the prefilled chamber 10 throughthe needle 35. During the injection stage that occurs following theactivated configuration, the second section 15 of the flexible body 13is depressed by causing an inversion of its shape towards the firstsection 14. The inversion of the second section 15 reduces the volumewithin the prefilled chamber 10 by forcing the contents to be expelledthrough the needle 35. When the second section 15 is fully inverted, theinterior walls of the second section 15 are coincident with the interiorwalls of the first section 14. The volume within the prefilled chamber10 is completely voided resulting in zero holdback space. By providing aconstruction that resulting zero holdback space, the flexible body 13will be unable to be reused. With the contents of the prefilled chamber10 emptied, the ampoule 1 is in the deactivated configuration. It shouldbe noted that in the BFS manufacturing process, a narrowed closed offsection, known as a neck, is formed when sealing off a filled containersection, analogous to the ampoule, of a mold.

While the neck feature is ubiquitous in the BFS manufacturing process isdoes create additional space within a fill container section thattranslates into a holdback space for a fluid. The preferred embodimentof the present invention positions the collar 22 within the formed neckof the ampoule 1 resulting in a “no-neck” design that eliminatesholdback space.

In some embodiments of the present invention, it may be necessary forthe present invention to have a neck due to manufacturing reason or someother kind of additional utility. The neck is formed between the ampoule1 and the collar 22 of the insert body 2. The drawback of having such aneck is that the neck increases the volume within the ampoule 1 andconsequently prevents the present invention from achieving minimalholdback space, which occurs following the ejection of a medicatedsolution through the needle during an injection. In these embodiments,the present invention can be configured with different features in orderto reduce the additional volume created by the neck. One such feature isa mechanism that inserts a rigid filler into the neck in order to occupythe additional volume during the injection process. Another such featureis to make the neck out of a collapsible material that folds upon itselfnear the neck, reducing the internal volume created by said neckfeature. Still another feature would be the inclusion of a collapsiblesection on the ampoule 1 near the neck feature. The collapsible sectionwould fold upon itself reducing the internal volume of the ampoulefacilitating a minimal holdback space. In the aforementioned embodiment,the ampoule 1 creates indentations within the neck that would reduce theadditional volume.

Referencing FIG. 1, FIG. 2, and FIG. 5-10, the parison layer 12 of theampoule 1 secures the ampoule 1 to the upper section 20 of the insertbody 2. The parison layer is a material layer that engages the uppersection 20 through the BFS process. The parison layer 12 of the ampoule1 is formed during the formation of the prefilled chamber 10 and theflexible body 13. The parison layer initially forms a tubular structurethat sleeves the insert body 2. The insert body 2 is oriented into thetubular structure with the upper section 20 directed towards theprefilled chamber 10. It should be noted that the insert body 2 may beparticularly weighted to orient the upper section 20 towards theprefilled chamber 10 when used in a gravity fed assembly process. Thetubular section would be molded over the upper section 20. The knurlfeatures 21 of the upper section 20 and the knurl features 220 of thecollar 22 provide a plurality of ridges that enable the parison layer 12of the ampoule 1 to effectively engage the collar 22 during the moldingprocess. It should be noted that the parison layer 12 of the ampoule 1is differentiated from the parison layer 61 of the overtube 6 since theparison layer 12 of the ampoule 1 is retained to the upper section 20 bythe knurl features 21 of the upper section 20 and the knurl features 220of the collar 22. It should be noted that the parison layer 61 of theovertube 6 and the parison layer 12 of the ampoule 1 can be created fromthe same tubular section during the BFS process.

Referencing FIG. 1-4, the overtube 6 is the protective material thatsurrounds the insert body 2 and the needle cap 5. The overtube 6 servesas a tamper evident feature as well as a means of preventing the needlecap 5 from compressing the needle assembly 3 into the ampoule 1. Theovertube 6 is made from the same material as the ampoule 1 and is moldedover the insert body 2 and the needle cap 5 during the BFS process. Theovertube 6 comprises a parison layer, a pair of formed tabs 63, and afrangible feature 62. The parison layer 61 of the overtube 6 is moldedover the insert body 2 and needle cap 5 while in the initialconfiguration. Unlike the parison layer 12 of the ampoule 1, the parisonlayer 61 of the overtube 6 does not engage knurl features that wouldhelp retain the parison layer 61 of the overtube 6 to the insert body 2or the needle cap 5. The lack of retaining features engaging the parisonlayer 61 of the overtube 6 allows the overtube 6 to be removed from itsposition. The parison layer 61 of the overtube 6 does reach an adjacentpositioning to the parison layer 12 of the ampoule 1. The parison layer61 of the overtube 6 and the parison layer 12 of the ampoule 1 areseparated by the frangible feature 62. The frangible feature 62separates the parison layer 12 of the ampoule 1 from the parison layer61 of the overtube 6. The frangible features 62 can be accomplished byscoring or by the thinning of the parison layer. The frangible feature62 is broke allowing the overtube 6 to remove from the single useinjector. The breaking of the frangible feature 62 is facilitated by theuse of the pair of formed tabs 63. The pair of formed tabs 63 islaterally positioned on the overtube 6 coincident with the cylindricalwall 23 of the insert body 2. The formed tabs 63 are formed during theBFS process and serves as gripping surfaces for a user's hand. A user isable to rotate the overtube 6 by grasping the laterally positionedformed tabs 63 and rotating the overtube 6 in either a clockwise orcounterclockwise rotation. Upon separation of the parison layer 61 ofthe overtube 6 from the parison layer 12 of the ampoule 1, at thefrangible feature 62, the user would pull the overtube 6 away exposingthe insert body 2 and the needle cap 5.

In the current embodiment of the present invention, the ampoule 1 andthe overtube 6 are constructed from Low Density Polyethylene (LDPE).LDPE is selected as it has several properties favorable to themanufacturing of the single use injector. LDPE can be formulated withparticular elastic properties that allow the formation of the flexiblebody 13 of the ampoule 1. LDPE can be formulated to meet standards of apharmaceutical grade polymer that include those for sterility as well asbeing unlikely to react with a medication over an extended period oftime. LDPE has favorable melting temperatures that would be optimallysuited for the BFS manufacturing process. LDPE additionally hasfavorable binding properties with Polypropylene (PP).

In the current embodiment of the present invention, the insert body 2,the needle assembly 3, the shield assembly 4, and the needle cap 5 areconstructed using polypropylene (PP), with the exception of the needle35 and the spring 36. PP is a material that is favorable in theconstruction of the aforementioned components due to it rigid butpliable construction. PP formed components are able to hold their shapesafter being formed. Furthermore, PP components have favorableinteractions with LPDE components, as LDPE does not fuse to PPcomponents allowing for the separation of an LDPE layer from a PPcomponent.

In the current embodiment of the present invention, the insert body 2,the needle assembly 3, the shield assembly 4, and the needle cap 5 wouldbe assembled into the initial configuration prior to being positionedinto a mold with the ampoule 1 and the overtube 6. The insert body 2,the needle assembly 3, and the needle 35 shield have complicatedinteraction that can require additional attention to ensure that theyare properly assembly. By providing the aforementioned components in apre-assembled state, the BFS aspect of the assembly of the single useinjector wouldn't need specialized tools or mechanisms to individuallycouple each tool.

In another embodiment of the present invention and with reference toFIG. 12, the ampoule 1 may further comprise a bellows 17 and a push tab18. The bellows 17 is a device which is used to produce a strong blastof air to push liquid from the prefilled chamber 10 and out through theneedle 35. The push tab 18 is a flat portion that provides a push-downsurface for the user when squeezing the ampoule 1. The bellows 17comprises a series of pleats 171. The series of pleats is the folds ofthe bellows 17. The prefilled chamber 10 is compressibly surrounded bythe bellows 17 in order for the bellows 17 to push liquid from theprefilled chamber 10 and out through the needle 35. A last pleat 172from the series of pleats 171 tapers towards the parison layer 12 of theampoule 1 in order to maintain the design consistency of the ampoule 1.The last pleat 172 from the series of pleats 171 and the upper section20 are encasably retained by the parison layer 12 of the ampoule 1. Thisarrangement properly positions and connects the bellows 17 to the insertbody 2. The push tab 18 is connected adjacent to a first pleat 173 fromthe series of pleats 171, opposite to the last pleat 172 from the seriesof pleats 171. This arrangement properly positions the push tab 18 ontothe ampoule 1 in order for the user to easily and efficiently squeezethe ampoule 1.

With reference to FIG. 13, the present invention may further comprise anannular groove 7 and an annular rim 8. The annular grove 7 and theannular rim 8 are used to securely attach the ampoule 1 to the insertbody 2. The annular groove 7 is laterally integrated into the uppersection 20. This arrangement properly positions the annular groove 7onto the insert body 2. The annular rim 8 is connected within theparison layer 12 of the ampoule 1 and is detachably engaged to theannular groove 7. This properly positions the annular rim 8 within theampoule 1 in order for the user to attach or detach the ampoule 1 to andfrom the insert body 2.

With reference to FIGS. 14 and 15 and in another embodiment of thepresent invention, the needle cap 5 may further comprise a seal 54 inorder to securely attach the needle cap 5 to the insert body 2. The seal54 may be any type of security fastener which is used to ensure thepresent invention has not been tampered with and to allow the needle cap5 to be properly secured to the insert body 2. The seal 54 isperipherally connected to the sleeve mount 51 and is positioned oppositeto the rim 52. This arrangement properly positions the seal 54 to theneedle cap 5. Furthermore, the sleeve mount 51 is laterally andhermetically attached to the insert body 2 by the seal 54. Thisarrangement allows the seal 54 to be twisted or shaped off when thepresent invention is to be used in order for the user to remove theneedle cap 5 from the insert body 2, and to reattach the seal 54 inorder to securely attach the needle cap 5 back onto the insert body 2after the present invention is used.

Although the invention has been explained in relation to its preferredembodiment, it is to be understood that many other possiblemodifications and variations can be made without departing from thespirit and scope of the invention as hereinafter claimed.

What is claimed is:
 1. A single use injector comprises: an ampoule; aninsert body; a needle assembly; a shield assembly; the ampoule comprisesa prefilled chamber and a first parison layer; the insert body comprisesan upper section, a cylindrical wall, an inner chamber, a first pair ofslots and a second pair of slots; the needle assembly comprises alateral wall, a cavity, a needle, a spring, and a pair of snappinghooks; the shield assembly comprises activation tabs and a barrel; theampoule, the insert body, the needle assembly, and the shield assemblybeing centrally aligned; the needle assembly and the shield assemblybeing mounted into the insert body; the ampoule being mounted adjacentto the insert body, opposite the needle assembly and the shieldassembly; the prefilled chamber being secured against the upper sectionby the first parison layer; the needle assembly being moveably alignedwithin the inner chamber through the cylindrical wall; the needleassembly being directionally biased towards the upper section of theinsert body; the needle being piercingly aligned with the upper sectionand the prefilled chamber, wherein the needle is aligned to piercethrough the upper section and into the prefilled chamber; the barrel ofthe shield assembly being extendably positioned around the needle by wayof the spring; the activation tabs being actuatably engaged to thelateral wall of the needle assembly; the shield assembly beingextendably positioned around the needle; each snapping hook of the pairof snapping hooks comprises a flexible arm and a stud; the stud beingoutwardly extended from the flexible arm; the pair of snapping hooksbeing oppositely connected to the lateral wall across the cavity; acorresponding snapping hook among the pair of snapping hooks beingaccommodated within a corresponding lateral through hole among a pair oflateral through holes of the lateral wall; each slot of the first pairof slots being positioned across the inner chamber on the cylindricalwall, away from the upper section; each slot of the second pair of slotsbeing positioned across the inner chamber on the cylindrical wall,adjacent to the upper section; the first pair of slots being alignedwith the second pair of slots towards the upper section; the pair ofsnapping hooks being configured to be detachably coupled to the firstpair of slots by the stud being detachably engaged with a correspondingslot among the first pair of slots; the pair of snapping hooks beingconfigured to be detachably coupled to the second pair of slots by thestud being detachably engaged with a corresponding slot among the secondpair of slots; the stud being configured to be compressibly coincidentto the cylindrical wall by way of the flexible arm; the stud and theflexible arm being compressed inwardly towards the cavity in response tothe stud moving in between a corresponding slot among the first pair ofslots and a corresponding slot among the second pair of slots; theneedle assembly comprises a tapered spring mount; the shield assemblycomprises a spring mount; the spring mount comprises a needle passage;the lateral wall comprises needle shield activation channels; the springcomprises a first spring end and a second spring end; the activationtabs comprise an elongated arm, a first engagement feature, and a secondengagement feature; each of the needle shield activation channelscomprises a first path, a second path and an obstructing feature; eachof the first path and the second path laterally penetrating the lateralwall by being excised from the lateral wall; the first path and thesecond path intersecting each other at the obstructing feature with anacute angle; the needle comprises an injection end; the second pathcomprises a locking mount; the tapered spring mount being centrallypositioned within the cavity, wherein the narrow end of the taperedspring mount being oriented towards the shield assembly; the taperedspring mount traverses the first spring end, wherein the wide end of thetapered spring mount being coincidently positioned with the first springend; the second spring end being compressibly retained against thespring mount; the needle centrally traverses through the tapered springmount and the needle passage; the elongated arm being compressiblycoupled adjacent the spring mount; the first engagement feature and thesecond engagement feature being positioned opposite the spring mount onthe flexible arm; the second engagement feature being actuatablyretained in the first path by way of the obstructing feature and thespring; the second engagement feature being compressibly aligned withthe second path by way of the first path; the first engagement featurebeing extendably coincident with the locking mount by way of the spring,wherein the first engagement feature securely engages the locking mount;and the barrel and the spring mount being extendably positioned aroundthe injection end by way of the spring.
 2. The single use injector asclaimed in claim 1 comprises: a needle cap; an overtube; the needle capcomprises a rim and a protective cover; the needle cap being centrallyaligned to the ampoule, the insert body, the needle assembly, and theshield assembly; the needle cap being compressibly positioned againstthe needle assembly by way of the rim; the needle being encloseablypositioned within the protective cover; the overtube being removeablypositioned surrounding the insert body and the needle cap; the needleassembly and the shield assembly being enclosed between the insert bodyand the needle cap; and the insert body being positioned between theampoule and the needle cap.
 3. The single use injector as claimed inclaim 2 comprises: the overtube comprises a second parison layer, formedtabs, and frangible features; the needle cap comprises a sleeve mount;the upper section comprises knurl features; the knurl features beingpositioned on the upper section immediately adjacent to the cylindricalwall; the rim being positioned perpendicular the sleeve mount and theprotective cover; the sleeve mount being moveably positioned around thecylindrical wall, wherein movement of the sleeve mount compresses therim against the lateral wall; the second parison layer being removeablypositioned top of the insert body and the needle cap; the formed tabsbeing laterally positioned on the second parison layer on the overtube;and the frangible features being positioned between the second parisonlayer and the first parison layer, wherein the frangible features beingpositioned adjacent to the knurl feature.
 4. The single use injector asclaimed in claim 2 comprises: the needle cap further comprises a sleevemount and a seal; the seal being peripherally connected to the sleevemount; the seal being positioned opposite to the rim; and the sleevemount being laterally and hermetically attached about the insert body bythe seal.
 5. The single use injector as claimed in claim 1, wherein thepair of snapping hooks being immovably retained to the second pair ofslots.
 6. The single use injector as claimed in claim 1 comprises: theinsert body comprises a chamber opening and a pair of alignmentchannels; the needle assembly comprises a pair of guides and a cavityopening; the cavity opening being positioned adjacent to the chamberopening; the pair of alignment channels being recessed into an interiorsurface of the cylindrical wall adjacent to the cavity opening, whereinthe interior surface of the cylindrical wall is the surface coincidentwith the cavity; the pair of guides being peripherally positioned on thelateral wall adjacent to the cavity opening, wherein the peripheralpositioning places the pair of guides on the exterior surface of thelateral wall; each guide of the pair of guides being moveably positionedwithin an alignment channel of the pair of alignment channels, whereineach guide of the pair of guides travels along the length of analignment channel of the pair of alignment channels; and the needleassembly being moveably aligned along the length of the pair ofalignment channels.
 7. The single use injector as claimed in claim 1comprises: the upper section of the insert body comprises a collar andknurl features; the ampoule comprises a flexible body; the collarcomprises knurl features; the prefilled chamber comprises a medication,an inert gas, and a membrane; the inert gas and the medication beinghermetically sealed within the prefilled chamber; the prefilled chamberbeing compressibly surrounded by the flexible body; the collar beingprotrudingly positioned on the upper section towards the prefilledchamber, wherein the collar being raised relative to the upper section;the knurl features of the upper section being perimetrically positionedadjacent to the cylindrical wall, wherein the knurl features revolve theperimeter of the upper section adjacent the cylindrical wall; the knurlfeatures of the collar being perimetrically positioned around thecollar, perpendicular to the upper section; the flexible body beingtapered towards the collar; the flexible body and the upper sectionbeing encasably retained by the first parison layer; and the firstparison layer being moldably coupled to the knurl features of the uppersection and the knurl features of the collar.
 8. The single use injectoras claimed in claim 6 comprises: the flexible body comprises a firstsection and a second section; the first section of the flexible bodybeing symmetrically aligned with the second section of the flexible bodyenclosing the prefilled chamber; the first section of the flexible bodybeing tapered towards the collar; the second section of the flexiblebody being compressibly coupled to the first section of the flexiblebody; and the second section of the flexible body being configured to becompressed into first section of the flexible body for completelyexpelling the contents of the prefilled chamber.
 9. The single useinjector as claimed in claim 6 comprises: the ampoule comprises anadhesive membrane; and the prefilled chamber being breachably coupled tothe collar by way of the adhesive membrane, wherein the prefilledchamber being breachable by the needle through the adhesive membrane.10. The single use injector as claimed in claim 1 comprises: the needleassembly comprises a conical shaped needle mount; the upper sectioncomprises a collar; the inner chamber comprises a conical shaped cavity;the collar comprises a guide shaft and a septum; the needle comprises apuncturing end, an injection end, and a fluid conduit; the collar beingprotrudingly positioned on the upper section towards the prefilledchamber, wherein the collar being raised relative to the upper section;the conical shaped cavity being centrally positioned on the uppersection opposite the collar, wherein the conical shaped cavity beingcoincident with the inner chamber; the conical shaped needle mount beingperpendicularly positioned to the lateral wall adjacent to the conicalshaped cavity; the needle centrally traverses the conical shaped needlemount, wherein the conical shaped needle mount being positioned betweenthe puncturing end and the injection end; the septum being piercinglyaligned to the puncturing end, wherein the puncturing end being alignedto traverse the septum; the puncturing end being centrally aligned withthe guide shaft, wherein the guide shaft being slightly wider indiameter to the puncturing end in order to orient it after piercing theseptum; the conical shaped needle mount being coincidently aligned withthe conical shaped cavity, wherein the concavity of the conical shapedcavity being positioned to receive the conical shaped needle mount; thepuncturing end being breachably aligned within the prefilled chamber;and the injection end being in fluid communication with the prefilledchamber by way of the puncturing end through the fluid conduit.
 11. Thesingle use injector as claimed in claim 9 comprises: the conical shapedneedle mount being securely mounted to the conical shaped cavity,wherein the conical shaped needle mount being wider than the conicalshaped cavity causing the conical shaped needle mount to wedge into theconical shaped cavity forming a sealed connection.
 12. The single useinjector as claimed in claim 9 comprises: the puncturing end of theneedle comprises a rounded tip and a conduit opening; and the roundedtip being terminally positioned on the puncturing end shielding theconduit opening, wherein the rounded tip prevents obstructions of theconduit opening by sheered particles of the septum.
 13. The single useinjector as claimed in claim 1 comprises: the ampoule further comprisesa bellows and a push tab; the bellows comprises a series of pleats; theprefilled chamber being compressibly surrounded by the bellows; a lastpleat from the series of pleats tapering towards the first parisonlayer; the last pleat from the series of pleats and the upper sectionbeing encasably retained by the first parison layer; and the push tabbeing connected adjacent to a first pleat from the series of pleats,opposite to the last pleat from the series of pleats.
 14. The single useinjector as claimed in claim 1 comprises: an annular groove; an annularrim; the annular groove being laterally integrated into the uppersection; the annular rim being connected within the first parison layer;and the annular rim being detachably engaged to the annular groove.